Pooling device for single or multiple medical containers

ABSTRACT

A device is provided for pooling a fluid from a container unit having at least one container, and includes an inlet port having at least one inlet channel configured for receiving the fluid or ambient air, and an outlet port having at least one outlet channel configured for delivering the fluid to an attachment. Both inlet and outlet ports are disposed on the device. A cavity is provided for accommodating insertion of the container unit for pooling the fluid from the at least one container. At least one spike is disposed in the cavity and configured for puncturing a stopper of the at least one container when the container unit transitions from an upper position to a lower position.

CROSS-REFERENCE

The present application is a continuation of U.S. patent applicationSer. No. 15/186,061, filed on Jun. 17, 2016, which claims the benefit ofto U.S. provisional patent application serial No. 62/182,099, filed onJun. 19, 2015, each of which is incorporated by reference.

BACKGROUND

The present disclosure generally relates to pooling devices used formedical purposes, and more specifically to a device configured forpooling contents from medicinal containers for concurrent use.

In many cases, medicinal agents or fluids are separated before use fortheir chemical and physical stability. Thus, the fluids are packaged andstored individually until the fluids are mixed together to beadministered intravenously to a patient. Traditionally, the mixing ofthe fluids is achieved by a medical professional by injecting a firstfluid into a glass vial or container having a second fluid. After mixingthe first and second fluids, a mixed solution is withdrawn into asyringe barrel and intravenously injected into the patient. In certaincases, the two solutions are mixed in, or mixed solution is transferredto, a larger container, such as an intravenous (IV) administration bagor set, before delivery to the patient.

Some medicinal fluids are administered in sequence without mixing. Forexample, the first fluid may be administered initially to improve theconditions under which the second fluid is delivered to or processed bythe patient. An exemplary dual medical container unit for administeringthe first and second fluids is described in commonly assigned U.S. Pat.No. 8,684,433, which is incorporated by reference. In some cases,several vials of medicinal fluid must be combined to provide the correctdose to a patient. Patients suffering from certain immunodeficiencyconditions are treated with infusions of relatively large volumes ofImmunoglobulin (IG) fluid. A first fluid medication is applied toenhance the bodily reception to the relatively high viscosity IG fluid,which is the second medication. Conventionally, the medical professionaladministering the fluids verifies the identity and concentration of thefluids, swabs a corresponding stopper of each container using adisinfecting agent, such as alcohol, spikes the stopper of eachcontainer for the delivery of fluids, pools the fluids separately fromrespective containers using multiple syringes and pooling bags, and thensequentially performs the administration of the fluids on the patient.In certain cases, the dual container unit is manually elevated or hungfrom an IV pole so that one or more of the fluids are delivered bygravity flow to the pooling bag.

Due to this multi-step process, which in some cases is alternatelyperformed by the patient at home, the conventional administration methodis prone to mishandling and mistakes. For example, the bottles, vials orother containers may be mishandled, and could even end up damaged orbroken. Further, several manual steps are currently needed to achievethe desired sequence of administration in a sterile environment, asignificant amount of time is wasted due to the numerous manual steps,and a substantial space is required for storing an inventory ofequipment during use. if the sterile administration of the medicinalfluid could be compromised, bacterial or environmental contaminationcould result. Any of these issues may have a negative impact on theadministration of the fluids to the patient, and on the health of thepatient.

Thus, there is a need for developing an improved pooling device thatprovides an enhanced administration method for single or multiplemedicinal containers in a simpler and more reliable manner.

SUMMARY

The present disclosure is directed to a pooling device for pooling amedicinal fluid from at least one medical container, which integratesmany of the manual steps discussed above. An important aspect of thepresent pooling device is that a central cavity configured for receivingthe medical container is provided for pooling the medicinal fluid fromthe medical container without repeatedly loading different medicalcontainers. An internal lumen spike is disposed in the cavity forpuncturing a stopper of each medical container, and a locking mechanismis provided for securely holding the medical container in the cavity ofthe present pooling device.

In some embodiments, two or more present pooling devices are linkable orconnectable in a complementary relationship, such that separate medicalcontainers are sequentially automatically administered to a user orpatient without having to replace the medical container duringoperation. As an example only, an outlet of the present pooling deviceis linked or daisy-chained to an inlet of another pooling device forfacilitating an unbroken connection of the fluid path between all linkedpooling devices. In this configuration, two or more medicinal fluids canbe administered to the user in relatively high volumes (in the range of100's of ml) without interruption, or manipulation of the medicalcontainers. It is contemplated that the linked pooling devices can bereversed from the orientation described above.

In one embodiment, a pooling device is provided for pooling a fluid froma container unit having at least one container, and includes an inletport having at least one inlet channel configured for receiving thefluid or ambient air, and an outlet port having at least one outletchannel configured for delivering the fluid to an attachment. Both inletand outlet ports are disposed on the device. A cavity is provided foraccommodating insertion of the container unit for pooling the fluid fromthe at least one container. At least one spike is disposed in the cavityand configured for puncturing a stopper of the at least one containerwhen the container unit transitions from an upper position to a lowerposition.

In another embodiment, a pooling device is provided for pooling amedicinal fluid, and includes a container unit having at least onecontainer configured for storing the fluid, wherein the container unitis pre-attached to the pooling device. Also included in the poolingdevice is an inlet port having at least one inlet channel configured forreceiving the fluid or ambient air. An outlet port having at least oneoutlet channel is provided for delivering the fluid to an attachment.Both inlet and outlet ports are disposed on the pooling device. A cavityis provided for accommodating insertion of the container unit from thepre-attached position for pooling the fluid from the at least onecontainer. At least one spike is disposed in the cavity and configuredfor puncturing a stopper of the at least one container when thecontainer unit transitions from an upper position to a lower position.

In yet another embodiment, a device is provided for pooling a medicinalfluid, and includes a container unit having at least one containerconfigured for storing the fluid, wherein the container unit ispre-attached to the pooling device. An inlet port having at least oneinlet channel is provided for receiving the fluid or ambient air. Anoutlet port having at least one outlet channel is provided fordelivering the fluid to an attachment. Both inlet and outlet ports aredisposed on the pooling device. A cavity is provided for accommodatinginsertion of the container unit from the pre-attached position forpooling the fluid from the at least one container. At least one spike isdisposed in the cavity and configured for puncturing a stopper of the atleast one container when the container unit transitions from an upperposition to a lower position. The pooling device is complimentarilylinkable with another pooling device in a serial arrangement relative toa longitudinal axis of each pooling device for establishing anuninterrupted supply of the fluid from linked pooling devices.

In yet another embodiment, a pooling device is provided for pooling afluid from a container unit having at least one container, and includesan inlet port having at least one inlet channel configured for receivingthe fluid or ambient air. Also included in the pooling device is anoutlet port having at least one outlet channel configured for deliveringthe fluid to an attachment, and the inlet and outlet ports are disposedon the pooling device. A cavity is configured for accommodatinginsertion of the container unit for pooling the fluid from the at leastone container. At least one spike is disposed in the cavity andconfigured for puncturing a stopper of the at least one container whenthe container unit transitions from an upper position to a lowerposition.

More specifically, the inlet port is connected to the outlet port influid communication with the at least one spike via, a correspondingtube, and the at least one spike has a first spike channel beingconnected to the at least one inlet channel. Further, the at least onespike has a second spike channel being connected to the at least oneoutlet channel. At least one of the inlet and outlet ports has aprotective cover for guarding the corresponding inlet and outletchannels from contamination, and the at least one spike projectsnormally from an inner surface of a base of the pooling device.

A locking mechanism is provided for the pooling device and is configuredfor securely holding the container unit in the cavity during use, andthe locking mechanism is preferably disposed on an inner wall of thecavity. The cavity is configured for accommodating insertion of thecontainer unit for pooling the fluid from a single container. At leastone container is configured to store the fluid, and the container unitis attached to the pooling device. A lockout mechanism is provided forthe pooling device, and is configured for stopping the transition of thecontainer unit from the upper position to the lower position.

For the container unit, a lockout pin is included and is insertable intoa slot disposed on a body of the container unit. A press bar is disposedon a top of the container unit for transitioning the container unit fromthe upper position to the lower position by pushing the press bardownwardly. Advantageously, the pooling device is serially linkable withanother pooling device in a complementary relationship for establishingan uninterrupted supply of the fluid from linked pooling devices.Preferably, the inlet port of a first pooling device is configured to beinsertable into the outlet port of a second pooling device in acomplementary relationship. A first pooling device and a second poolingdevice are serially linked together in a complementary relationshiprelative to a longitudinal axis of each pooling device.

A cap remover is provided for the pooling device, and is attached to theat least one container and configured for removing a top cap of the atleast one container. A leakage prevention mechanism has a fluidconnection assembly configured for controlling a fluid path in thepooling device, and an air connection assembly configured forcontrolling an air vent path in the pooling device. The air connectionassembly includes an air path connector being connected to the inletport of the pooling device via a hydrophobic filter.

Included in the fluid connection assembly is a first fluid check valvebeing connected to the outlet port of the pooling device for selectivelyregulating a directional fluid flow of the fluid, and a second fluidcheck valve being connected to the inlet port of the pooling device forselectively regulating the directional fluid flow of the fluid. Thefirst fluid check valve has a first fluid path connector configured forreleasably complementarily connecting to a second check valve of anotherpooling device, and the second fluid check valve has a second fluid pathconnector configured for releasably complementarily connecting to thefirst fluid check valve of another pooling device. A cracking pressureof the first and second fluid check valves is in a range of 3-5 poundsper square inch.

Included in the air connection assembly is an air path plug or endcomponent member having a blind cavity configured for releasablycomplementarily connecting to the air path connector of another poolingdevice. The fluid connection assembly includes a first female memberhaving a first female member opening configured for accommodatinginsertion of a first male member of the fluid connection assembly. Also,the fluid connection assembly includes an assembly locking mechanismconfigured for releasably connecting the first female and male membersof the fluid connection assembly. Specifically, the first female memberhas a first sealing fixture configured for preventing a directionalfluid flow of the fluid, and the first male member has a second sealingfixture configured for preventing the directional fluid flow of thefluid. Further, the first female member has a column depending from aninner upper surface of the first female member, and the first malemember has a backup washer having a central throughbore dimensioned toaccommodate insertion of the column of the first female member. Alsoincluded in the air connection assembly is a second female member havinga second female member opening configured for accommodating insertion ofa second male member of the air connection assembly.

A hydrophobic filter is disposed in the second female member opening ofthe second female member, and the second male member is configured forcreating an air-tight interference-fit between the sheath and the secondfemale member. Preferably, the second male member is enclosed with asheath having an annular protrusion. A plurality of fluid and air pathtubes are provided in the pooling device, and the path tubes areconstructed and arranged for placing at least one of the air vent pathand the fluid path of the pooling device in fluid communication witheach other.

It is preferred that the air connection assembly is simultaneouslyconnected to and shared by at least two containers of the poolingdevice, and the fluid connection assembly includes a firstforce-activated valve being connected to the outlet port of the poolingdevice for selectively regulating a directional fluid flow of the fluid.Also, the fluid connection assembly includes a second force-activatedvalve being connected to the inlet port of the pooling device forselectively regulating the directional fluid flow of the fluid. Includedin the fluid connection assembly is a unidirectional check valve beingconnected to the inlet port of the pooling device for selectivelyregulating a directional fluid flow of the fluid.

At least one spike is enclosed with a spike sheath configured forconnecting the inlet and outlet ports of the pooling device in fluidcommunication. The fluid connection assembly includes a spike connectorand an access dome valve. Specifically, the access dome valve has anopening configured for accommodating insertion of the spike connector ina complementary relationship. The fluid connection assembly includes atleast one of: a hydrophobic filter and a hydrophilic filter. It ispreferred that the hydrophobic filter is connected to the inlet port ofthe pooling device for selectively regulating a directional air flow ofthe pooling device. Alternatively or additionally, the hydrophilicfilter is connected to the outlet port of the pooling device forselectively regulating a directional fluid flow of the pooling device.

A tray member includes at least one pooling device which is incorporatedinto the tray member in fluid communication. Preferably, the tray memberincludes a flow cover having at least one flow passageway and beingattached to the tray member for facilitating the fluid communication.Further, the tray member includes a positional valve configured forselectively regulating a flow path from at least one container. At leastone hydrophobic filter is connected to at least one of: the inlet portand the outlet port. Similarly, at least one hydrophilic filter isconnected to at least one of: the inlet port and the outlet port. Inanother embodiment, a tray member includes a plurality of poolingdevices incorporated into the tray member in fluid communication. Inthis configuration, it is preferred that the tray member includes twoseparate tubes configured for conveying two separate fluids from theplurality of pooling devices to the outlet port.

In yet another embodiment, a pooling device is provided for pooling amedicinal fluid, and includes a container unit having at least onecontainer configured to store the fluid, the container unit beingattached to the pooling device. An inlet port has at least one inletchannel configured for receiving the fluid or ambient air. An outletport has at least one outlet channel configured for delivering the fluidto an attachment, where the inlet and outlet ports are disposed on thepooling device. A cavity is configured for accommodating insertion ofthe container unit for pooling the fluid from the at least onecontainer. At least one spike is disposed in the cavity and configuredfor puncturing a stopper of the at least one container when thecontainer unit transitions from an upper position to a lower position.The pooling device is complementarily linkable with another poolingdevice in a serial arrangement relative to each pooling device forestablishing an uninterrupted supply of the fluid from linked poolingdevices. Also included in the pooling device is a first wing configuredfor accommodating the outlet port, and a second wing configured foraccommodating the inlet port. The second wing is vertically displacedrelative to the first wing.

The foregoing and other aspects and features of the disclosure willbecome apparent to those of reasonable skill in the art from thefollowing detailed description, as considered in conjunction with theaccompanying drawings.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a perspective view of a first embodiment of the presentpooling device, featuring an exemplary dual medical container unit andan exemplary infusion tubing set;

FIG. 2 is a plan view of the pooling device of FIG. 1 , featuringexemplary inlet and outlet ports for fluid delivery, and integratedspikes transversely disposed on an inner surface of the pooling devicefor puncturing stoppers of corresponding medical containers;

FIG. 3 is a partial plan of the pooling device of FIG. 2 , featuring theexemplary outlet port disposed on an outer surface of the pooling devicefor detachably connecting to the infusion tubing set;

FIG. 4 is a perspective view of a second embodiment of the presentpooling device having a lockout pin, illustrating an exemplaryarrangement of two adjacent pooling devices before connection;

FIG. 5 is a perspective view of the pooling devices of FIG. 4 afterconnection;

FIG. 6 is a schematic front view of the pooling devices of FIG. 5 ,featuring an exemplary illustration of a fluid path between theconnected medical containers;

FIG. 7 is a side perspective view of a third embodiment of the presentpooling device, illustrating another exemplary arrangement of twoconnected pooling devices having different configurations for thelockout pin and the inlet and outlet ports;

FIG. 8 is a rear perspective view of the pooling devices of FIG. 7 whenthe adjacent pooling devices are interconnected;

FIG. 9 is a rear perspective view of the pooling device of FIG. 7 whenthe adjacent pooling devices are disconnected;

FIG. 10 is a schematic front view of the pooling device of FIG. 5 ,featuring a leakage prevention mechanism having a fluid connectionassembly and an air connection assembly;

FIG. 10A is a schematic front view of the leakage prevention mechanismof FIG. 10 featuring an exemplary combination of two force-activatedvalues;

FIG. 10B is a schematic front view of the leakage prevention mechanismof FIG. 10 , featuring an exemplary combination of a force-activatedvalve and a unidirectional check valve;

FIG. 10C is a schematic front view of the leakage prevention mechanismof FIG. 10 , featuring an exemplary combination of a spike connector andan access dome valve;

FIG. 11 is a schematic front view of the pooling devices of FIG. 10 whenthe adjacent pooling devices are interconnected via the leakageprevention mechanism;

FIG. 12 is an exploded, fragmentary vertical cross-section of the fluidconnection assembly of FIG. 10 ;

FIG. 13 is an exploded, fragmentary vertical cross-section of the airconnection assembly of FIG. 10 ;

FIG. 14 is a vertical cross-section of the leakage prevention mechanismof FIG. 10 , illustrating a fluid path of the fluid connection assembly;

FIG. 15 is a bottom view of the leakage prevention mechanism of FIG. 10;

FIG. 16 is a bottom view of the leakage prevention mechanism of FIG. 10, configured for facilitating the dual medical container unit;

FIG. 17A is a top perspective view of an exemplary cap remover designedto be used with the pooling device of FIG. 1

FIG. 17B is a bottom perspective view of the cap remover of FIG. 17A;

FIGS. 17C-17D illustrate exemplary uses of the cap remover of FIG. 17A;

FIG. 18 is a schematic front view of the leakage prevention mechanism ofFIG. 10 featuring an exemplary combination of a hydrophobic filter and ahydrophilic filter;

FIG. 19 is an exploded perspective view of an exemplary trayincorporating the present pooling device in a serial arrangement; and

FIG. 20 is an exploded perspective view of an exemplary modular unitfeaturing the present pooling device with the hydrophobic filter.

DETAILED DESCRIPTION

Although a particular embodiment of the present pooling device has beendescribed herein, other alternate embodiments of all components relatedto the present pooling device are interchangeable to suit differentapplications. The term “pooling device” as used in this applicationrefers to a device for accessing the medicinal fluid from one or moremedical containers for administering the medicinal fluid to a patient.Thus, a pooling device used to administer medicinal fluid from a singlecontainer is contemplated, as well as several medical containers.

Referring now to FIGS. 1-3 , the present pooling device is generallydesignated 10 and is designed to pool a medicinal fluid or substancefrom a medical container unit, generally designated 12, having a firstmedical container 14 configured for storing a first medicinal fluid, anda second medical container 16 configured for storing a second medicinalfluid. In some embodiments, the present pooling device 10 is adisposable unit, to avoid potential contamination from re-use. Asdiscussed above, an exemplary dual medical container unit 12 isdescribed in commonly assigned. U.S. Pat. No. 8,684,433, which isincorporated by reference. While other medicinal substances arecontemplated for use with the present device 10, in one embodiment, thefirst medical container 16 contains an enzyme that enlarges pores in thesubcutaneous space of the patient. Enlargement of the pores facilitatethe delivery by infusion of high volumes of relatively high viscosity IGfluid, which is contained in the second container 14. For example,without the enzyme, an expected infusion of IG fluid is approximately 50ml at a single site. However, with the enzyme, infusions in the range of600 ml can be achieved at a single infusion site.

While the container unit 12 having two medical containers 14, 16 isshown, it is also contemplated that the container unit has a singlecontainer (e.g., a syringe, vial, film bag, ampule, and the like). Inone embodiment, the present pooling device 10 has a substantiallyrectangular shape when viewed from above, but other suitable shapes,such as oval, square, and other geometric shapes, are contemplated. Itis also contemplated that any number or combination of medicalcontainers can be used for the present pooling device 10 to suitdifferent applications.

Included in the present pooling device 10 is an inlet port 18 configuredfor receiving the medicinal fluid or ambient air, and the inlet port isdisposed on an outer wall 20 of the pooling device. In some embodiments,as described in greater detail below, the inlet port 18 receives themedicinal fluid from an adjacent pooling device (FIGS. 4 and 5 ) whenthe pooling devices are linked together. Otherwise, the inlet port 18acts as a vent for drawing ambient air while the pooling device 10 isnot linked to the adjacent pooling device. As described below inrelation to FIG. 6 , when the pooling devices 10 are linked together,the proper venting of air between the respective devices and containershas been found to enhance the sequential delivery of the medications.Depending on the configuration of the container unit 12, the inlet port18 may have one or more inlet channels 22, 24 that correspond to themedical containers 14, 16 during use.

For delivering the medicinal fluid from the pooling device 10, an outletport 26 is disposed on an opposite side of the outer wall 20 of thepooling device from the inlet port 18, and is configured for deliveringthe medicinal fluid to another medical attachment, such as the adjacentpooling device or an infusion tubing set 28, in some embodiments, theinfusion tubing set 28 is detachably connected at one end to the outletport 26 of the pooling device 10, and at an opposite end to a pumpingsystem (not shown), such as a peristaltic pump or an infusion device,for drawing the medicinal fluid from the pooling device 10.Alternatively, a syringe (not shown) can be docked to the outlet port 26for vacuum withdrawal of the medicinal fluid from the pooling device 10.

Regulating a flow of the medicinal fluid in the tubing set 28 isachieved by transversely adjusting at least one clamp 30 relative to alongitudinal axis of corresponding tubing. Other clamping devices thattransition between an occluding position and a non-occluding positionare contemplated as known in the art. As is the case with the inlet port18, the outlet port 26 may have one or more outlet channels 32, 34 thatcorrespond to the medical containers 14, 16 during use.

In some embodiments, each channel 22, 24, 32, 34 has a resilientlydeformable seal 36, such as an O-ring or the like, located at anentrance of the corresponding channel for facilitating a friction fit orslip-connection between connected inlet and outlet ports 18, 26, orbetween the outlet port 26 and the infusion tubing set 28. It iscontemplated that a removable protective cover 38 is friction fit overor around each port 18, 26 to guard the corresponding inlet and outletchannels 22, 24, 32, 34 from touch or air contamination.

In some embodiments, a central opening or cavity 40 configured foraccommodating insertion of the medical container unit 12 is provided forpooling the first and second medicinal fluids from the first and secondmedical containers 14, 16. Before the insertion of the medical containerunit 12 into the cavity 40, a top cap 42 of the medical container unitis removed to expose first and second stoppers 44, 46 of thecorresponding first and second containers 14, 16. Terminal sterilizationof the stoppers 44, 46 is performed using a disinfecting agent, such asalcohol, hydrogen peroxide, or the like.

A first lumen spike or needle 48 is disposed in the cavity 40 forpuncturing the first stopper 44 of the first medical container 14, and asecond lumen spike or needle 50 is disposed in the cavity for puncturingthe second stopper 46 of the second medical container 16. Both spikes48, 50 are preferably integrally transversely attached to an innersurface 52 of a base 54 of the pooling device 10, such that the spikesproject normally from the base for simultaneously puncturing the firstand second stoppers 44, 46 of the corresponding first and second medicalcontainers 14, 16. In certain cases, the first and second stoppers 44,46 of the corresponding first and second containers 14, 16 are puncturedseparately to suit different applications. In some embodiments, aprotective removable sleeve or sheath 56 is provided for each spike 48,50 to cover a sharp end point of each spike.

Initiation of medicinal fluid delivery is achieved by inverting thecontainer unit 12 and inserting the container unit into the cavity 40,such that the container unit transitions from an upper position to alower position. Specifically, in this depicted embodiment, during theinsertion, the first and second stoppers 44, 46 of the first and secondcontainers 14, 16 are pressed against and punctured by the first andsecond lumen spikes 48, 50, respectively. It is also contemplated thatthe protective seal provided by sleeve 56 is breached upon the inversionand downward insertion of the container unit 12. A biased, clip orclamp-type locking mechanism 58, disposed on an inner wall 60 of thecavity 40 in this depicted embodiment, is provided for holding thecontainer unit 12 spaced above the base 54 so that the containers 14, 16are unable to reach the spikes 48, 50 unless the containers arecorrectly located over the appropriate spike.

To facilitate proper orientation of the containers in the unit 12, asseen in FIG. 2 , the cavity 40 is dimensioned so that the container unit12 is keyed to the cavity so that it can only be inserted in the correctorientation. Once the containers 14, 16 are properly positioned in thecavity 40, the locking clips 58 are pushed radially outwardly by thepresence of the containers, which permits the container unit 12 totelescope, slide or move downwardly relative to the base 54, enablingengagement between the containers and the designated spike 48, 50. Thespikes 48, 50 pierce the stoppers 44. 46 of the corresponding containers14, 16 and initiates the delivery of the respective contained medicinalfluids.

To facilitate the fluid delivery of the first medicinal fluid, the firstspike 48 has a first spike channel 62 being connected, via correspondingtubing 64, to the first inlet channel 22. Further, the first spike 48has a second spike channel 66 being connected, via the correspondingtubing 64, to the first outlet channel 32. In a preferred embodiment, atleast one check valve 68 is interposed or installed in the tubing 64 toselectively control a directional flow of the medicinal fluid. It iscontemplated that the term “tube” or “tubing” includes or relates to anyfixed or flexible fluid passageways or paths, such as grooves and thelike, either separate from, or integral with the present pooling device10, having a variety of cross-sectional shapes (e.g., rounded, squared,or other shapes) depending on the application and construction methods.

It is contemplated that the tubing 64 is configured to interconnect theinlet port 18, the spikes 48, 50, and the outlet port 26, as known inthe art. As a result, upon activation of the pooling device 10, acontinuous flow path is established from the inlet port 18 to the outletport 26 in fluid communication with the first container 14. As describedin greater detail below in paragraphs related to FIGS. 10-16 , it isalso contemplated that a hydrophobic filter is used in the tubing 64 orother suitable locations of the pooling device 10 to allow air to passthrough, but prevent the medicinal fluid from leaking out of the poolingdevice. Additional check valves may be installed under the base 54 toprevent the medicinal fluid from traveling to a connected adjacent unitvia the spikes 48, 50.

More specifically, as illustrated in FIG. 2 , in a configuration wherethe present pooling device 10 is not linked to another pooling device,ambient air is drawn into the first container 14 (shown in phantom inFIG. 2 ) under the action of the pumping system via the first inletchannel 22, the corresponding tubing 64, and the first spike channel 62of the first spike 48. As a result, the first medicinal fluid in thefirst container 14 is delivered to the first outlet channel 32 via thesecond spike channel 66 of the first spike 48 and the correspondingtubing 64. An exemplary flow path of the air and the first medicinalfluid is designated with a broken-line arrow A.

When the delivery of the first medicinal fluid is completed, thedelivery of the second medicinal fluid may be initiated by controllingopening and closing of the clamps 30 (FIG. 3 ). To facilitate the fluiddelivery of the second medicinal fluid, the second spike 50 has a firstspike channel 70 being connected, via the corresponding tubing 64, tothe second inlet channel 24. Further, the second spike 50 has a secondspike channel 72 being connected, via the corresponding tubing 64, tothe second outlet channel 34. Consequently, upon activation of thepooling device 10, another continuous flow path is established from theinlet port 18 to the outlet port 26 in fluid communication with thesecond container 16 (shown in phantom in FIG. 2 ).

Specifically, as is the case with the first spike 48, ambient air isdrawn into the second container 16 under the action of the pumpingsystem via the second inlet channel 24, the corresponding tubing 64, andthe first spike channel 70 of the second spike 50. As a result, thesecond medicinal fluid in the second container 16 is delivered to thesecond outlet channel 34 via the second spike channel 72 of the secondspike 50 and the corresponding tubing 64. An exemplary flow path of theair and the second medicinal fluid is designated with a broken-linearrow B.

Referring now to FIGS. 2 and 4-6 , another embodiment of the presentpooling device 10 is generally designated 74 a, 74 b, 74 c. In FIGS. 4-6, corresponding components of first, second, and third pooling devices74 a, 74 b, 74 c are indicated with reference numbers with first threealphabet (i.e., “a,” “b,” and “c”) designations. Components shared withthe pooling device 10 are designated with identical reference numbers.In the particular embodiment shown in the pooling device 74 a, 74 b, 74c, the medical container unit 12 having the first and second containers14, 16 is attached to the pooling device 74 a, 74 b, 74 c as apre-assembled unit.

More specifically, the first and second stoppers 44, 46 of thecontainers 14, 16 are inserted into the cavity 40 of the pooling device74 a, 74 b, 74 c, and ready to be punctured by the first and secondspikes 48, 50 (FIG. 2 ). In the present pooling device 74 a, 74 b, 74 c,it is contemplated that each device 74 would be terminally sterilized,such as by with gamma radiation or the like, to guarantee a sterilefluid path. The spikes 48, 50 are provided with the protective sheaths56, that are punctured and compressed as the containers 14, 16 aredepressed, thereby keeping the spikes clean and the fluid path sterileuntil use.

Then, the device 74 and container unit 12 are assembled and sealed intoa breathable package and treated with a disinfecting agent, such ashydrogen peroxide vapor or the like, to keep the stoppers 44, 46 and thespikes 48, 50 in a sanitized condition until use.

In this configuration, the first and second stoppers 44, 46 of thecontainers 14, 16 are pre-staged or pre-positioned in the upper positionto be punctured by the first and second spikes 48, 50. However, alockout mechanism or pin 76 configured for stopping the transition ofthe container unit 12 from the upper position to the lower positionprevents premature activation of the pooling device 74 a, 74 b, 74 cbefore use (e.g., during shipping and handling). Thus, the pin 76performs a similar function to the locking clips 58 discussed above. Itis contemplated that the lockout pin 76 is inserted into a slot 78disposed on a body 80 of the container unit 12 between the first andsecond containers 14, 16, but other suitable configurations of thelockout pin are contemplated.

After the lockout pin 76 is disengaged by pulling it out of the body 80,a press bar 82 having a plurality of grooves 84 for grip enhancingpurposes is disposed on a top of the container unit 12, and is pusheddownwardly to transition the container unit from the upper position tothe lower position. This downward movement of the container unit 12causes the first and second stoppers 44, 46 of the containers 14, 16 tobe punctured by the corresponding first and second spikes 48, 50.

In some embodiments of the present pooling device, as in the depictedembodiments, 74 a, 74 b, 74 c, two or more pooling devices may beserially linked together in a complementary relationship relative to alongitudinal axis of each pooling device for establishing anuninterrupted supply of the medicinal fluid from the linked poolingdevices. For example, as illustrated in FIGS. 4 and 5 , the inlet port18 a of the first pooling device 74 a is inserted into andcomplementarily connected with the outlet port 26 b of the secondpooling device 74 b. In turn, the inlet port 18 b of the second poolingdevice 74 b is inserted into the outlet 26 c of the third pooling device74 c for facilitating an unbroken connection of the fluid path betweenall linked pooling devices 74 a, 74 b, 74 c.

In this configuration, the first, second, and third pooling devices 74a, 74 b, 74 c are connected or linked in fluid communication with oneanother for providing a passageway between the pooling devices for theuninterrupted, continuous delivery of the medicinal fluids. For example,the first medicinal fluids of the linked first containers 14 a, 14 b, 14c can be administered to the user without interruption or manipulationof the containers. Similarly, the second medicinal fluids of the linkedsecond containers 16 a, 16 b, 16 c can be subsequently administered tothe user. It is contemplated that the pooling devices 74 a, 74 b, 74 ccan be arranged in any other suitable manner to facilitate theadministration of the medical fluids. Further, the first and secondmedicinal fluids may he delivered to the user in a reverse order to suitthe application.

Referring now to FIGS. 5 and 6 , an embodiment with a flow path forthree linked first containers 14 a, 14 b, 14 c is shown for illustrationpurposes. In this configuration, ambient air is drawn into the rightfirst container 14 c via the inlet port 18 c and the first spike channel62 c of the first spike 48 c. The second spike channel 66 c of the firstspike 48 c is connected to the first spike channel 62 b of the firstspike 48 b in the middle first container 14 b. Similarly, the secondspike channel 66 b of the first spike 48 b is connected to the firstspike channel 62 a of the first spike 48 a in the left first container14 a.

Next, the second spike channel 66 a of the first spike 48 a is connectedto the pumping system via the outlet port 26 a shown on the left of thefirst container 14 a in FIG. 6 . Another flow path of three linkedsecond containers 16 a, 16 b, 16 c is established in a similar fashion.

In operation, a negative or suction pressure created by the pumpingsystem through the port 26 a causes an uninterrupted sequential deliveryof the first medicinal fluid from three first containers 14 a, 14 b, 14c. The system 74 a-c has a built in air/fluid management feature forproviding sequential delivery of the medication from the respectivecontainers 14 a-c. For example, initially, the fluid in the left firstcontainer 14 a is drawn down by the suction pressure applied via theport 26 a and spike channel 66 a to the fluid content of the container14 a until a vacuum develops above the level of fluid in that container14 a. The buildup of this vacuum pressure creates a suction pressure onthe fluid content of the container 14 b via the fluid connection of thespike channel 62 a and inlet channel 18 a to the outlet channel 26 b andspike channel 66 b.

Next, the suction pressure exerted on the fluid content in the middlefirst container 14 b draws down the contents until a similar vacuumdevelops above the level of fluid in that container. Once the vacuum isdeveloped in both containers 14 a and 14 b, a suction pressure iscreated on the fluid content of the container 14 c via the fluidconnection of the spike channel 62 b and inlet channel. 18 b to theoutlet channel 26 c and spike channel 66 c. Since the container 14 c isvented to ambient through line 18 c, only a slight vacuum pressure iscreated above the liquid contents of this container 14 c. Instead, thecreated suction pressure will be communicated to ambient via the spikechannel 62 c and inlet port 18 c and will cause the drawing of air intothis container 14 c and this container will empty first.

The container 14 c will empty until the liquid level reaches below theentrance to spike channel 66 c, whereby the interior of next container14 b will become exposed to ambient via container 14 c, allowing thefluid contents of the container 14 b to be emptied under the suctionforce of the pumping system. Lastly, after the container 14 b isemptied, the container 14 a is then emptied in a similar fashion.Accordingly, three containers 14 a, 14 b, 14 c, are sequentiallyautomatically administered in a distal to proximate order until all ofthe containers are empty.

A different volumetric amount of each container 1.4 a, 14 b, 14 c doesnot affect this sequential fluid delivery process. Exemplary volumetricamounts of standard vials include 25, 50, 100, 200, and 300 milliliters,but any other suitable size or combination of medical containers arecontemplated. Referring now to FIGS. 2 and 7-9 , yet another (third)embodiment of the present pooling device 74 is generally designated 86a, 86 b. In FIGS. 7-9 , corresponding components of first and secondpooling devices 86 a, 86 b are indicated with reference numbers withfirst two alphabet (i.e., “a” and “b”) designations. Components sharedwith the pooling device 74 are designated with identical referencenumbers. A major difference featured in the pooling devices 86 a, 86 bis that the pooling devices are linked or daisy-chained, together in aserial arrangement relative to the longitudinal axis of each poolingdevice.

More specifically, each pooling device 86 a, 86 b includes a first orleft wing 88 a, 88 b configured for accommodating the outlet port 26 a,26 b, and a second or right wing 90 a, 90 b configured for accommodatingthe inlet port 18 a, 18 b. As for the first pooling device 86 a shown inFIG. 9 , the first and second inlet channels 22 a, 24 a are disposed onthe second wing 90 a, and the first and second outlet channels 32 a, 34a are disposed on the first wing 88 a. The second pooling device 86 bhas the same configuration for the corresponding inlet and outletchannels.

As illustrated in FIGS. 8 and 9 , to establish daisy-chained coupling oftwo adjacent pooling devices 86 a, 86 b, the second wing 90 a of thefirst pooling device 86 a is complementarily connected with the firstwing 88 b of the second pooling device 86 b. More specifically, in apreferred embodiment, the second wing 90 a is positioned higher than thefirst wing 88 b relative to an axis transverse to a longitudinal axis ofthe pooling device 86 a, 86 b. It is contemplated that the relativepositions and configurations of the first and second wings 88 b, 90 acan be reversed from the orientation described above.

It is also preferred that the first and second inlet channels 22 a, 24 aextend downwardly from a lower surface of the second wing 90 a, and thefirst and second outlet channels 32 b, 34 b extend upwardly from anupper surface of the first wing 88 b. Thus, the daisy-chained couplingof the pooling devices 86 a, 86 b is achieved by pressing the secondwing 90 a of the first pooling device down onto the first wing 88 b ofthe second pooling device, such that the inlet channels 22 a, 24 a ofthe first pooling device are inserted into the outlet channels 32 b, 34b of the second pooling device in a complementary arrangement.

Returning to FIGS. 2, 7 and 9 , another feature of the pooling device 86a, 86 b is that the protective cover 38 has an elongate body configuredto accommodate a contour or profile of the first and right wings 88 a,88 b, 90 a, 90 b. Optionally, the protective cover 38 has an auxiliaryport 92 configured for delivering the medicinal fluid from thecontainers 16 a and 16 b through the corresponding outlet port 26 a, 26b into a syringe, for example, docked to the auxiliary port 92. Theprotective cover 38 also has a tubing set configured for delivering themedical fluid from other containers 14 a and 14 b to an infusion pumpconnected to a patient for infusion. In lieu of the lockout pin 76 (FIG.5 ), a locking spacer 94 is provided to prevent the container unit 12from transitioning to the lower position. Initially, the locking spacer94 is inserted into a circumferentially extending annular groove 96disposed on an upper portion 98 of the corresponding pooling device 86a, 86 b to lock the container unit 12 in the upper position.

As similarly operated with the lockout pin 76, after the locking spacer94 is removed from the pooling device 86 a, 86 b by pulling a ring 100attached to the spacer, the press bar 82 of the container unit 12 ispushed downwardly to transition the container unit from the upperposition to the lower position. This downward movement of the containerunit 12 causes the first and second stoppers 44, 46 of the containers14, 16 to be punctured by the corresponding first and second spikes 48,50.

Referring now to FIGS. 6, and 10 , an exemplary leakage preventionmechanism is generally designated 102, and is designed to preventunwanted air or fluid leakage from the pooling device 10. Componentsshared with the pooling device 10 are designated with identicalreference numbers. Included in the leakage prevention mechanism 102 area fluid connection assembly, generally designated 104, configured forcontrolling a fluid path in the pooling device 10, and an air connectionassembly, generally designated 106, configured for controlling an airvent path in the pooling device. It is contemplated that the leakageprevention mechanism 102 is applicable to all embodiments of the poolingdevices 10, 74, 86, described above.

In a preferred embodiment, the fluid connection assembly 104 includes afirst fluid valve 108 being integrated into the outlet port 26 of thefirst pooling device 74 for selectively regulating the fluid flow of themedicinal fluid from the first container 14. The first fluid valve 108is typically closed when not connected to another device or tubingconnector, and is mechanically opened to allow the fluid flow via aconnector 114 when connected to another device or tubing connector. Thefluid connection assembly 104 includes a second fluid check valve 110being connected to the inlet port 18 of the first pooling device 74 forselectively regulating the directional fluid flow of the medicinal fluidto the first container 14.

It is contemplated that the fluid check valve 110 is one-directionalvalve allowing the fluid path only toward the first container 14, suchthat the medicinal fluid in the first container does not leak out of thecontainer when the first and second fluid check valves are in a restingposition. The first valve 108 has a first fluid path connector 112configured for releasably complementarily connecting to the second checkvalve 110 of another pooling device. Optionally, the second check valve110 has a second fluid path connector 114 configured for releasablycomplementarily connecting to the first check valve 108 of anotherpooling device.

During use, the first fluid valve 108 prevents the fluid flow from thefirst container 14 when the pooling device 74 is not connected toanother pooling device. The valve is mechanically opened to allow freefluid flow when connected to another device 74. The second fluid checkvalve 110 prevents leakage from the connector 114 when the device 74 isnot connected to another pooling device, and also prevents unwantedleakage between connected pooling devices 74. An exemplary crackingpressure of the fluid check valve 110 is approximately 3-5 pounds persquare inch (PSI) to allow the valve to be opened by fluid pressurecreated by a connected pump.

For selectively regulating a directional air flow of the pooling device74, the air connection assembly 106 includes an air path connector 116being connected to the inlet port 18 of the first pooling device 74 viaa hydrophobic filter 118. Specifically, the hydrophobic filter 118 isconnected at one end to the air path connector 116, and at an oppositeend to the spike 48 downstream of the fluid check valve 110. As known inthe art, the hydrophobic filter 118 allows air passage, but preventsfluid from traveling through the filter. Thus, the hydrophobic filter118 prevents unwanted leakage of the medicinal fluid from the air pathconnector 116. Alternatively, other suitable hydrophilic filters arealso contemplated to suit different applications.

An air path plug or end component 120 having a blind cavity 122 isprovided in the air connection assembly 106, and is configured forreleasably complementarily connecting to the air path connector 116 ofanother pooling device. When the air path plug 120 and the air pathconnector 116 are matingly or complementarily connected, the air ventpath in the pooling device 74 is obstructed or blocked by the blindcavity 122, thereby effectively preventing air leakage.

Referring now to FIGS. 2, 6, and 11 it is contemplated that the firstpooling device 74 a is linked or daisy-chained to the second poolingdevice 74 b (FIG. 11 ). Corresponding components of the leakageprevention mechanism 102 a, 102 b and the first and second poolingdevices 74 a, 74 b are indicated with reference numbers with first twoalphabet (i.e., “a” and “b”) designations. In this configuration, theair path plug 120 b of the second air connection assembly 106 b ismatingly or complementarily connected to the air path connector 116 a ofthe first air connection assembly 106 a. Thus, when the first and secondpooling devices 74 a, 74 b are linked or daisy-chained, the air ventpaths of the connected pooling devices are automatically closed orblocked except the air vent path of the most distal device of thedaisy-chained devices (e.g., the air vent path defined by the air pathconnector 116 b of the second air connection assembly 106 b).

As for the fluid path, the first fluid path connector 112 b of the firstfluid valve 108 b of the second fluid connection assembly 104 b ismatingly or complementarily connected to the second fluid path connector114 a of the second fluid check valve 110 a of the first fluidconnection assembly 104 a. It is also contemplated that the pumpingsystem is connected to the first fluid path connector 112 a of the firstfluid valve 108 a of the first fluid connection assembly 104 a in fluidcommunication with the container 14 a.

In this configuration, the connected first valves 108 a, 108 b aremechanically opened by the first fluid path connectors 112 a, 112 b forallowing the fluid communication between the pumping system and thepooling devices 74 a, 74 b. However, neither of the second check valves110 a, 110 b needs to be mechanically opened because the fluid flow fromthe second pooling device 74 b to the first pooling device 74 a isalready accommodated by the one-directional second check valve 110 a.Only the first valves 108 a, 108 b) that do not allow the fluid flow outof the containers 14 a, 14 b are mechanically opened.

As described similarly above, ambient air is drawn into the container 14b of the second pooling device 74 b via the air path connector 116 b andthe hydrophobic filter 118 b of the air connection assembly 106 b.Simultaneously, the second check valve 110 b of the second fluidconnection assembly 104 b of the second pooling device 74 b prevents thefluid leakage from the container 14 b. As a result, the negativepressure, such as vacuum, created by the pumping system causes anuninterrupted sequential delivery of the medicinal fluids from thecontainers 14 a, 14 b without any unwanted fluid leakage.

Referring now to FIGS. 10 and 12 , it is preferred that the fluidconnection assembly 104 includes a female member 124 having a femalemember opening 126 configured for accommodating the insertion of a malemember 128 of the fluid connection assembly. For securely attaching thefemale member 124 to the male member 128, a snap-fit assembly lockingmechanism, generally designated 130, is provided in the, fluidconnection assembly 104, and configured for releasably connecting thefemale and male members 124, 128 together.

In a preferred embodiment, the locking mechanism 130 includes at leastone locking tab or protrusion 132 being disposed on an inner surface ofa side wall 134 of the female member 124, and at least one indent orgroove 136 being disposed on an outer surface of the male member 128.When the male member 128 is slidingly inserted into the female memberopening 126, the locking tab 132 and the corresponding indent 136 of thelocking mechanism 130 are matingly latched for securely holding thefemale and male members 124, 128 in place, thereby initiating thedirectional fluid flow of the medicinal fluid, as designated by an arrowC. Other locking mechanism structures, such as annular locking andreleasing grooves, lateral wings, and the like, are contemplated.

An important aspect of the fluid connection assembly 104 is that thefemale member 124 has a first sealing fixture 138 attached to an outerupper surface of the, female member for providing a fluid-tightcompression seal. It is contemplated that the first sealing fixture 138has a first concave side 140 and an opposite first convex side 142, andthe seal is designed to be opened when a pressure is applied against thefirst concave or convex side 140, 142. Preferably, the first sealingfixture 138 has a substantially dome shape, and is made of a flexible,elastomeric material. It is contemplated that a first slit or gap 144having a predetermined length is disposed at a substantially center ofthe first sealing fixture 138, such that the slit is tightly closed atrest but opened when the pressure is applied against the first concaveor convex side 140, 142.

More specifically, the first slit 144 of the first sealing fixture 138prevents the fluid flow of the medicinal fluid when the first sealingfixture is in a resting position. However, when the negative pressurecreated by the pumping system is applied to the convex side 142 of thefirst sealing fixture 138, the first slit 144 is opened to allow thefluid flow of the medicinal fluid, as designated by the arrow C. Othersuitable types of check valves, such as spring-loaded ball check valves,duckbill valves, umbrella valves, diaphragm valves, or the like, arecontemplated to suit the application.

It is also contemplated that the female member 124 has a tubular column146 depending from a substantially center of an inner upper surface ofthe female member 124 within the female member opening 126 along alongitudinal axis of the female member. Preferably, the tubular column146 has an inclined or sloped outer surface 148 with a lead-in geometry,resulting in a funnel shaped outer wall. Specifically, an outer diameterof the tubular column 146 is gradually increased toward the inner uppersurface of the female member 124. Other suitable geometric shapes, suchas square, rectangular, hexagonal shapes, are also contemplated for thecolumn 146.

Another important aspect of the fluid connection assembly 104 is thatthe male member 128 is substantially tubular and has a second sealingfixture 150 attached to an inner surface of the male member forproviding the fluid-tight compression seal. As with the first sealingfixture 138, the second sealing fixture 150 has a second concave side152 and an opposite second convex side 154. As described above, thesecond sealing fixture 150 has the same configuration of the firstsealing fixture 138, and operates the same way as the first sealingfixture. However, it is noted that the first and second sealing fixtures138, 150 are disposed in opposite orientations for preventing the fluidleakage from the fluid connection assembly 104.

More specifically, the first sealing fixture 138 is disposed on theouter upper surface of the female member 124, such that the first convexside 142 is faced upwardly along a longitudinal axis of the femalemember in a fluid flow direction, as designated by the arrow C. Incontrast, the second sealing fixture 150 is disposed on the innersurface of the male member 128, such that the second convex side 154 isfaced downwardly along a longitudinal axis of the male member againstthe fluid flow direction, as designated by the arrow C. Thus, at rest, asecond slit or gap 156 of the second sealing fixture 150 prevents thefluid flow of the medicinal fluid from the male member 128, and thefirst slit or gap 144 of the first sealing fixture 138 prevents thefluid flow of the medicinal fluid from the female member 124.

It is also contemplated that the male member 128 has a female memberopening 158 configured for accommodating the insertion of the tubularcolumn 146 of the, female member 124. An elastomeric backup washer 160having a central throughbore 162 is disposed near an upper end of theinner surface of the male member 128. Since the central throughbore 162of the backup washer 160 is dimensioned to accommodate the insertion ofthe tubular column 146 of the female member 124, an inner diameter ofthe throughbore is slightly smaller than a smallest outer diameter ofthe tabular column. Thus, as the tubular column 146 of the female member124 is gradually inserted into the central throughbore 162 of the backupwasher 160, a fluid-tight interference-fit is :formed between thetubular column and the backup washer. As the tubular column 146 iscompletely inserted, it forces open the slit 156 and allows fluidcommunication between the female member 124 and the male member 128.

Referring now to FIGS. 10 and 13 it is preferred that the air connectionassembly 106 includes a female member 164 having a female member opening166 configured for accommodating the insertion of a male member 168 ofthe air connection assembly. An important aspect of the female member164 of the air connection assembly 106 is that the hydrophobic filter118 is disposed near a lower end of an inner surface of the femalemember 164. For example, the hydrophobic filter 118 is attachable to theinner surface of the female member 164 by chemical adhesives, solventboding, ultrasonic welding or other conventional fastening techniques.

A rigid cylindrical body 170 of the male member 168 is enclosed with aflexible, elastomeric sheath 172 having an annular protrusion 174, suchthat as the male member 168 is gradually inserted into the female memberopening 166, the annular protrusion creates an air-tight interferencefit between the sheath and the female member 164. Thus, it is preferredthat an outer diameter of the annular protrusion 174 is slightly greaterthan an inner diameter of the female member opening 166. Although ahollow inner portion 176 of the male member 168 is shown forillustration purposes, any suitable solid or semi-solid material can beseparately inserted into or integrally formed with the inner portion ofthe male member to suit the application.

Referring now to FIGS. 2, 10-12, and 14 , an exemplary fluid path of thefluid connection assembly 104 is illustrated in FIG. 14 . As discussedabove, it is contemplated that the pumping system is connected to themale member 128 of the fluid connection assembly 104. The pumping systemwould have a tubing set with a female connector 124 similar to the oneon the pooling devices. When the tubing set with the female connector124 is connected to a pooling device, the tubular column 146 inside ofthe female connector 124 will force open the slit 156 in the maleconnector 128 of the pooling device, thereby allowing the fluid flow ofthe medicinal fluid from the medical container 14 via the second spikechannel 66 and the outlet port 26.

When the female member 124 of the fluid connection assembly 104 isconnected to the male member 128 of another adjacent pooling device 74,the negative pressure causes the first sealing fixture 138 of the femalemember to open. As a result, the medicinal fluid from the adjacentpooling device will flow into the medical container 14 via the firstspike channel 62 and the inlet port 18, for establishing theuninterrupted supply of the medicinal fluid from the linked ordaisy-chained pooling devices. It is contemplated the sealing fixtures138, 150 and the washer 160 are made of flexible, resilient materials,such as synthetic resin or plastic, rubber, or the like. Other suitablematerials are also contemplated to suit the application.

It is contemplated that the fluid path of the medicinal fluid of thepooling device 74 is incorporated into an injection molded assembly asan integral unit. For example, in some embodiments, the male member 128of the fluid connection assembly 104 is preferably integrallytransversely attached to the base 54 of the pooling device 74, such thatthe male member projects normally from the base. In this configuration,as similarly shown in FIGS. 8 and 9 , when the female and male members124, 128 are connected to each other, an enhanced secure coupling oflinked pooling devices is achieved, thereby preventing from an unwanteddisassembly of the linked devices. It is also contemplated that therelative positions and configurations of the female and male members124, 128 can be reversed from the orientation described above.

Referring now to FIGS. 10-12, 14, and 15 , it is contemplated that aplurality of fluid and air path grooves 178 are molded into the base 54of the pooling device 74 for forming at least a portion of the fluidpath of the medicinal fluid. In this configuration, the inlet port 18and the outlet port 26 are integrated into the grooves 178 as a singleunit, so that the fluid and air paths from the spike 48 to the fluid andair connection assemblies 104, 106 are seamlessly transitioned.

More specifically, as for the fluid path, the female member opening 126of the female member 124 of the fluid connection assembly 104 isconnected to the first spike channel 62 of the spike 48 via the groove178 in fluid communication with the medical container 14, and the secondspike channel 66 of the spike 48 is connected to the male member opening158 of the male member 128 of the fluid connection assembly usinganother groove, thereby forming a continuous fluid path from the femalemember 124 to the male member 128.

As for the air vent path, the female member opening 166 of the femalemember 164 of the air connection assembly 106 is connected to the firstspike channel 62 of the spike 48 via the groove 178 in fluidcommunication with the medical container 14, such that the ambient airis drawn into the medical container 14 when the female member of the airconnection assembly is not plugged by the male member 168 of the airconnection assembly.

In some embodiments, a protective plate 180 (FIG. 14 ) is used to coverand seal the fluid and air paths defined by the grooves 178. Attachmentof the plate 180 to the base 54 is achieved by chemical adhesives,solvent boding, ultrasonic welding or other conventional fasteningtechniques. A shape of the plate 180 is variable depending on the shapesof the grooves, but other suitable geometric shapes, such as square,rectangular, or oval shapes, are contemplated to suit the application.

Referring now to FIGS. 1, 2, 14, and 16 , another exemplary layout ofthe grooves 178 of the leakage prevention mechanism 102 is illustratedwherein the grooves are constructed and arranged for facilitating thedual medical container unit 12. Corresponding components of the fluidconnection assembly 104 are indicated with reference numbers with firsttwo alphabet (i.e., “a” and “b”) designations. An important aspect ofthis groove configuration is that although two separate or distinctfluid connection assemblies 104 a, 104 b are included in the leakageprevention mechanism 102, only one air connection assembly 106 isincluded and shared by the first and second spikes 48, 50.

Specifically, the female member opening 166 of the female member 164 ofthe air connection assembly 106 is connected to both the first spikechannel 62 of the first spike 48 and the first spike channel 70 of thesecond spike 50 via the grooves 178, such that the ambient air receivedthrough the female member of the air connection assembly flowssimultaneously into both the first and second medical containers 14, 16.While a “T”-shaped air vent path layout of the grooves 178 is shown forillustration purposes, other suitable arrangements, such as “Y”- and“V”-shaped layouts, are also contemplated to suit the application.

Referring now to FIGS. 2, 10A-10C and 14 , it is also contemplated thatthe fluid connection assembly 104 includes a first force-activated valve182 (FIG. 110A.) being connected to the outlet port 26 of the poolingdevice 74 for selectively regulating a directional fluid flow of thefluid. In a similar configuration, the fluid connection assembly 104includes a second force-activated valve 184 (FIG. 10A) being connectedto the inlet port 18 of the pooling device 74 for selectively regulatingthe directional fluid flow of the fluid.

For example, as illustrated in FIG. 10B, the second force-activatedvalve 184 is disposed between the second fluid check valve 110 and thefirst spike 48, and connected to the inlet port 18, such that the fluidflow from the connector 114 is controlled by operation of the secondforce-activated valve, for preventing the fluid leakage from the fluidconnection assembly 104. It is preferred that a unidirectional checkvalve 186 is connected to at least one of the inlet port 18 and theoutlet port 26 of the pooling device 74 for selectively regulating thedirectional fluid flow of the fluid.

Specifically, to activate the second force-activated valve 184 and thusallow the fluid flow in the inlet port 18, the first medical container14 is pushed downwardly to transition the first medical container fromthe upper position to the lower position, as designated by an arrow D(FIG. 10B). This downward movement of the first medical container 14causes a top portion 188 of the first medical container 14 to depressthe corresponding force-activated valve 184 and allow the fluid flowfrom the connector 114. Conversely, when the second force-activatedvalve 184 is not activated, the fluid flow is prevented in the inletport 18. Other suitable locations along the fluid or air flow connectingto the inlet port 18 and the outlet port 26 are also contemplated tosuit different applications.

Similarly, the activation of the first or second force-activated valve182, 184 shown in FIG. 10A is achieved by matingly or complementarilyinterconnecting the first fluid path connector 112 of the fluidconnection assembly 104 of the pooling device 74 to the second fluidpath connector 114 of the fluid connection assembly 104 of anotherpooling device. As discussed above, an exemplary interconnection of twoadjacent pooling devices 74 a, 74 b is shown in FIG. 11 .

It is also contemplated that at least one of the spikes 48, 50 isenclosed with a spike sheath 190 (shown in phantom in FIG. 14 )configured for connecting the inlet and outlet ports 18, 26 of thepooling device 74 in fluid communication. For example, in an initialposition, the spike sheath 190 simultaneously and securely encloses thefirst spike channel 62 and the second spike channel 66 of the firstspike 48, thereby allowing the air flow or the fluid flow between theinlet and outlet ports 18, 26 of the pooling device 74.

However, as shown in FIG. 10B, the spike sheath 190 is puncturable andcompressible as the container 14 is depressed. As discussed above, whenthe first medical container 14 transitions from the upper position tothe lower position, as designated by the arrow D, the spike sheath 190is also pushed downwardly by the top portion 188 of the container 14from the upper position shown in FIG. 14 to the lower position shown inFIG. 10B. By this movement of the container 14, the spike sheath 190 isbroken, and the fluid flow between the inlet and outlet ports 18, 26 isachieved.

Referring now to FIGS. 10C and 14 , the fluid connection assembly 104includes a spike connector 192 and an access dome valve 194. It ispreferred that the spike connector 192 is connected to the inlet port 18of the pooling device 74, and the access dome valve 194 is connected tothe outlet port 26 of the pooling device. As described above, the accessdome valve 194 has the configuration similar to the second sealingfixture 150 of the snap-fit locking mechanism 130 shown in FIG. 14 . Inthis configuration, the access dome valve 194 has the opening orthroughbore 162 configured for accommodating insertion of the spikeconnector 192 in a complementary relationship.

Referring now to FIGS. 1, 8, and 17A-17D, the pooling device 74 includesa cap remover 198 attached to at least one of the pooling devices andconfigured for removing the top cap 42 of the corresponding container.In a preferred embodiment, the cap remover 198 includes a central cavity200 having a head region 202 and a tail region 204, wherein the head andtail regions are disposed, preferably inwardly, in opposite orientationsfrom each other around the cavity in use, the head region 202 of the capremover 198 engages or grasps the top cap 42, and pivots about a pointnear the tail region 204 for opening the top cap, as designated by anarrow E (FIG. 17C). While a substantially round or oval shape of the capremover 198 is shown in FIGS. 17A-17C for illustrative purposes, othersuitable shapes or designs, such as multilateral or irregular shapes,are contemplated to suit the application.

As shown in FIG. 17D, it is also contemplated that the head region 202of the cap remover 198 is preferably integrally formed with the base 54of the pooling device 10. In this configuration the head region 202 ofthe cap remover 198 is fixedly attached to the base 54 of the poolingdevice 10 without the tail region 204. During use, the top cap 42 of themedical container unit 12 is positioned in an inverted position next tothe pooling device 10 so that the head region 202 at the base 54 canengage or fit snuggly with the top cap of the container. Next, thecontainer 14 pivots about a point opposite the head region 202 relativeto the top cap 42, such that the container is pulled away from thepooling device 10 for opening the top cap, as designated by an arrow E′.

Referring now to FIGS. 1, 10, and 18 , it is contemplated that in someembodiments the fluid connection assembly 104 includes at least one of ahydrophobic filter 206 and a hydrophilic filter 208. In someembodiments, the hydrophobic filter 206 is connected to the inlet port18 of the pooling device 10 for selectively regulating a directionalair/fluid flow of the pooling device. Conversely, the hydrophilic filter208 is connected to the outlet port 26 of the pooling device 10 forselectively regulating the directional fluid and air flow of the poolingdevice.

In an exemplary configuration of FIG. 18 , which is constructed andarranged for facilitating the dual medical container unit 12, a firsthydrophobic filter 206′ is connected to a first inlet port 18′ for the,first medical container 14 configured for storing the first medicinalfluid. Similarly, a second hydrophobic filter 206″ is connected to asecond inlet port 18″ for the second medical container 16 configured forstoring the second medicinal fluid. Thus, it is advantageous that thefirst and second hydrophobic filters 206′, 206″ allow air to vent 3without any unwanted fluid leakage from the inlet ports 18′, 18″.

To selectively control the directional fluid flow of the first or secondmedicinal fluid, the hydrophilic filter 208 is connected to both a firstoutlet port 26′ for the first medical container 14, and a second outletport 26″ for the second medical container 16. In this configuration, thehydrophilic filter 208 advantageously allows air to vent until itbecomes wet by the first or second medicinal fluid, after which thehydrophilic filter allows only the medicinal fluid to travel through thefluid path connector 112.

As an example only, when the first medical container 14 is empty offluid, the hydrophilic filter 208 prevents air from passing thehydrophilic filter and being infused into a patient. This blocking ofair also stops any fluid flow and causes the pump to sound an alarm,which signals the patient/caregiver to move the positional valve 216 toopen the flow path to second medical container 16. Next, the pumpoperation is resumed to infuse the contents of second medical container16. If the hydrophilic filter 208 is also installed in the outlet port216″, then the hydrophilic filter prevents air from passing the filterand being infused into the patient when the medical container 16 isempty. This blocking of air stops any fluid flow and causes the pump tosound an alarm, which signals the patient/caregiver that the infusion ofthe second medical fluid is complete. Other suitable arrangements of thehydrophobic and hydrophilic filters 206, 208 are also contemplated tosuit different applications.

Referring now to FIGS. 1, 6, 7, 10, 11 and 19 , it is contemplated thata tray member 210 includes at least one present pooling device 74 linkedin a serial arrangement, incorporating the pooling device into the traymember in fluid communication. In FIG. 19 , while four (4) poolingdevices 74 are incorporated into the tray member 210, any number orembodiment of the pooling devices are contemplated to suit theapplication. A flow cover 212 having at least one flow path orpassageway 214 is attached to the tray member 210 to facilitate thefluid communication between the pooling devices 74. It is preferred thata first flow passageway 214 is provided for connecting the first medicalcontainers 14, and a separate second flow passageway 214″ is providedfor connecting the second medical containers 16. In this example, thetray member 210 includes a plurality of pooling devices 74 incorporatedinto the tray member in fluid communication. Further, the tray member210 includes two separate tubes or passageway 214, 214″ configured forconveying two separate fluids from the first and second medicalcontainers 14, 16 to the outlet port 52. Components shared with thepooling device 10 shown in FIGS. 1, 6 and 11 are designated withidentical reference numbers.

It is preferred that the tray member 210 includes a positional valve 216configured for selectively allowing or regulating the fluid path from atleast one of the first and second medical containers 14, 16. Forexample, the positional valve 216 is a manual switch or stopcock havinga twist valve configured for selectively allowing and blocking the fluidflow from the first and/or second medical containers 14, 16. It is alsocontemplated that the positional valve 216 provides a valved access forpreventing the fluid flow when the tubing set 28 is detached from thetray member 210. In a preferred embodiment, a spike cap 218 is providedto protect the spike sheath 190 and the spikes 48, 50. As an example, inFIG. 19 , the fluid path connector 112 is replaced with the positionalvalve 216 for one path to the other at point 108. It is contemplatedthat the positional valve 216 has a luer lock connector and is axiallyrotatable so that the user controls which fluid is delivered to theuser.

Referring now to FIGS. 1, 4, 7-9 and 20 , it is preferred that thepooling device 74, 86 a is constructed and arranged as a stackable,linkable modular unit. Components shared with the pooling devices 10,74, 86 a are designated with identical reference numbers. As similarlyshown in FIGS. 4 and 7-9 , it is contemplated that the pooling device 86a includes the first wing 88 a configured for accommodating the outletport 26 a, and the second wing 90 a configured for accommodating theinlet port 18 a.

To prevent unwanted leakage of the first and second medicinal fluids, asshown in FIG. 20 , for example, a first hydrophobic filter 118′ isdisposed at the inlet port 18 a and connected to the first spike 48, anda second hydrophobic filter 118″ is disposed at the second wing 90 a andconnected to the second spike 50. Other suitable arrangements of thehydrophobic filters 118′, 118″ are contemplated to suit differentapplications.

As shown in FIG. 20 , it is contemplated that the pooling device 86 aincludes the flow cover 212 having at least one dedicated flow path orpassageway 214′, 214″ for facilitating the fluid flow from therespective spike 48, 50. Each flow path 214′, 214″ is bifurcated orseparated according to the spike channels 62. 66, 70, 72 of thecorresponding spike 48, 50 using a dividing member 220. It is alsocontemplated that at least one protective plate or cover 222 is providedto seal exposed fluid or air paths or passageways associated with thepooling device 86 a. Further, at least one cap member 224 is provided todetachably block the fluid or air path or passageway associated with thepooling device 86 a.

While a particular embodiment of the present pooling device has beendescribed herein, it will be appreciated by those skilled in the artthat changes and modifications may be made thereto without departingfrom the present disclosure in its broader aspects, and as set forth inthe following claims.

What is claimed is:
 1. A device for pooling a medicinal fluid,comprising: a first inlet; a first outlet; a first cavity configured toaccommodate insertion of a first container unit, wherein the firstcontainer unit includes at least a first container configured to store afirst fluid; a first spike disposed in the first cavity and configuredto puncture a stopper of the first container when the first containerunit transitions from an upper position to a lower position, wherein thefirst spike includes a first channel connected to the first inlet, and asecond channel connected to the first outlet; a second cavity configuredto accommodate insertion of a second container unit, wherein the secondcontainer unit includes at least a second container configured to storea second fluid; a second spike disposed in the second cavity andconfigured to puncture a stopper of the second container when the secondcontainer unit transitions from an upper position to a lower position,wherein the second spike includes a third channel connected to the firstinlet via the first channel and the second channel, and the second spikeincludes a fourth channel connected to the first outlet, wherein thesecond channel is connected to the first outlet via the third channeland the fourth channel; and a spike sheath of the second spike coveringthe second spike and connecting the third channel and the fourth channelof the second spike in fluid communication to allow fluid to flow fromthe second channel of the first spike to the first outlet.
 2. The deviceof claim 1, wherein the spike sheath of the second spike is removablefrom the second spike.
 3. The device of claim 1, wherein the spikesheath of the second spike is configured to be punctured and compressedwhen the second container unit transitions from the upper position tothe lower position.
 4. The device of claim 1, further comprising a spikecap configured to protect the second spike and the spike sheath of thesecond spike.
 5. The device of claim 1, wherein the first container unitincludes a third container configured to store a third fluid, furthercomprising: a second inlet; a second outlet; and a third spike disposedin the first cavity and configured to puncture a stopper of the thirdcontainer when the first container unit transitions from the upperposition to the lower position, wherein the third spike includes a fifthchannel connected to the second inlet, and a sixth channel connected tothe second outlet.
 6. The device of claim 5, further comprising a spikesheath of the third spike covering the third spike and connecting thefifth channel and the sixth channel of the third spike in fluidcommunication.
 7. The device of claim 5, wherein the second containerunit includes a fourth container configured to store a fourth fluid,further comprising: a fourth spike disposed in the second cavity andconfigured to puncture a stopper of the fourth container when the secondcontainer unit transitions from the upper position to the lowerposition, wherein the fourth spike includes a seventh channel connectedto the second inlet and a eighth channel connected to the second outlet.8. The device of claim 7, further comprising a spike sheath of thefourth spike covering the fourth spike and connecting the seventhchannel and the eighth channel of the fourth spike in fluidcommunication.
 9. The device of claim 8, wherein the fifth channel isconnected to the second inlet, the sixth channel is connected to theseventh channel, and the eighth channel is connected to the secondoutlet.
 10. The device of claim 8, further comprising a spike sheath ofthe third spike covering the third spike and connecting the fifthchannel and the sixth channel of the third spike in fluid communication,wherein: the spike sheath of the second spike is configured to bepunctured and compressed when the second container unit transitions fromthe upper position to the lower position, the spike sheath of the thirdspike is configured to be punctured and compressed when the firstcontainer unit transitions from the upper position to the lowerposition, and the spike sheath of the fourth spike is configured to bepunctured and compressed when the second container unit transitions fromthe upper position to the lower position.
 11. The device of claim 8,further comprising the first container unit and the second containerunit, wherein the first fluid and the second fluid are the same type offirst fluid, and wherein the third fluid and the fourth fluid are thesame type of third fluid, and wherein the first fluid and the thirdfluid are different fluids.
 12. A method of operating a device forpooling a medicinal fluid, the method comprising: moving a firstcontainer unit including at least a first container containing a firstfluid from an upper position to a lower position as the first containerunit is inserted into a first cavity; piercing a stopper of the firstcontainer with a first spike disposed in the first cavity; allowing thefirst fluid to flow from the first container into the first spike andinto a first channel of a second spike disposed in a second cavity; andallowing the first fluid to flow from the first channel of the secondspike to a second channel of the second spike, and to an outlet of thedevice, wherein the first channel and the second channel of the secondspike are fluidly connected by a spike sheath of the second spikecovering the second spike, wherein the spike sheath of the second spikeremains unpunctured while the first fluid is allowed to flow to theoutlet of the device.
 13. The method of claim 12, further comprising:piercing a stopper of a second container included with the firstcontainer unit with a third spike disposed in the first cavity, whereinthe second container contains a second fluid; and puncturing andcompressing a spike sheath of the third spike covering the third spikeas the first container unit transitions from the upper position to thelower position.
 14. The method of claim 12, further comprising: moving asecond container unit including at least a third container containing athird fluid from an upper position to a lower position as the secondcontainer unit is inserted into the second cavity; piercing a stopper ofthe third container with the second spike; puncturing and compressingthe spike sheath of the second spike as the second container unittransitions from the upper position to the lower position; and allowingthe third fluid to flow to the second channel of the second spike and tothe outlet of the device.
 15. The method of claim 13, furthercomprising: allowing a second fluid to flow from the second containerinto the third spike and into a first channel of a fourth spike disposedin the second cavity; and allowing the first fluid to flow from thefirst channel of the fourth spike to a second channel of the fourthspike, and to a second outlet of the device, wherein the first channeland the second channel of the fourth spike are fluidly connected by aspike sheath of the fourth spike covering the fourth spike, wherein thespike sheath of the fourth spike remains unpunctured while the secondfluid is allowed to flow to the second outlet of the device.
 16. Themethod of claim 15, further comprising: moving a second container unitincluding at least a third container containing a third fluid from anupper position to a lower position as the second container unit isinserted into the second cavity; piercing a stopper of the thirdcontainer with the second spike; puncturing and compressing the spikesheath of the second spike as the second container unit transitions fromthe upper position to the lower position; and allowing the third fluidto flow to the second channel of the second spike and to the outlet ofthe device.
 17. The method of claim 16, wherein the second containerunit includes a fourth container containing a fourth fluid, wherein themethod further comprises: piercing a stopper of the fourth containerwith the fourth spike as the second container unit moves from the upperposition to the lower position; puncturing and compressing the spikesheath of the fourth spike as the second container unit transitions fromthe upper position to the lower position; and allowing the fourth fluidto flow to the second channel of the fourth spike and to the outlet ofthe device.
 18. The method of claim 17, wherein the first fluid and thethird fluid are the same type of first fluid, and wherein the secondfluid and the fourth fluid are the same type of second fluid, andwherein the first fluid and the second fluid are different fluids. 19.The method of claim 12, further comprising puncturing and compressing aspike sheath of the first spike covering the first spike as the firstcontainer unit transitions from the upper position to the lowerposition.
 20. The device of claim 1, further comprising a spike sheathof the first spike covering the first spike and connecting the firstchannel and the second channel of the first spike in fluidcommunication.